Safety and Pharmacokinetics Study of CPL500036 Compound in Healthy Volunteers

NCT ID: NCT03873324

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-09-16

Brief Summary

The planned study is to determine the safety and pharmacokinetic properties of CPL500036 compound after single and multiple (two weeks) administration in healthy volunteers.

Detailed Description

This is to be one-centre, single ascending dose and double-blind multiple ascending dose two part study of CPL500036 compound in healthy volunteers.

PART A is a single dose, open-label part with CPL500036 compound administered with dose escalation between cohorts.

PART B is a multiple, double-blind part with CPL500036 compound administered for 14 days with dose escalation between cohorts. Participants in this part are to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.

Safety and pharmacokinetic properties of CPL500036 compound is to be determined following different doses in single oral IMP administration in PART A and different doses of IMP administered orally for two weeks in PART B.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CPL500036

PART A: 7 cohorts are to receive single dose of IMP. Each participant is to take single dose of IMP. There is to be dose escalation between cohorts.

PART B: 4 cohorts are to receive multiple dose of IMP. Each participant is to take IMP once daily for 14 days. There is to be dose escalation between cohorts.

Group Type: EXPERIMENTAL

CPL500036 compound

Intervention Type: DRUG

IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).

Placebo

PART B: 2 Participants from 4 cohorts (total of 8 people) are to receive masking placebo capsules once daily for 14 days. There is to be dose escalation between cohorts. Participants are to be randomized within cohorts.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo capsules

Interventions

CPL500036 compound

IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).

Intervention Type: DRUG

Placebo

matching placebo capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Caucasian female or male,
• Age: 18-55 years old, inclusive,
• Body-mass index (BMI): ≥18.5 kg/m^2 and <29.9 kg/m^2,
• Non-smoker and nonuser of tobacco products for at least 3 months before screening,
• Physical examination without any clinically relevant abnormality,
• Laboratory values not clinically significant,
• Volunteer (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

Exclusion Criteria

• Known allergy or hypersensitivity to other drugs similar in structure or class to CPL500036 compound, or to any excipients of the formulation,
• Any known significant current or past acute or chronic disease or condition,
• Participation in other clinical trial within 90 days preceding the screening,
• Blood drawn within 30 days prior to inclusion to the study (more or equal to 300mL),
• Positive results from pregnancy test for female participants,
• Lactation in women participants,
• Hypotension or hypertension in medical history,
• Long QT interval syndrome or is under the treatment with antiarrhythmic drugs,
• Narcotic, alcohol addiction or abuse,
• Participant who adhere to a special diet (e.g. low calories, vegetarian).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Research and Development, Poland

OTHER

Sponsor Role: collaborator

Celon Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BioResearch Group Sp. z o.o.

Kajetany, Nadarzyn, Poland

Countries

Poland

Other Identifiers

01PDE2018

Identifier Type: -

Identifier Source: org_study_id